Business Services Specialist executing and supporting operational excellence across Argentina, Chile, and Peru in a biopharmaceutical company. Collaborating with teams to enhance compliant execution and business efficiency.
About the role
- Compliance Manager leading compliance initiatives at Medisca, a global healthcare solutions provider. Ensuring regulatory adherence and overseeing vendor programs across multiple jurisdictions.
Responsibilities
- Plan, manage, and execute compliance-focused initiatives across multiple global jurisdictions
- Communicate potential risks and mitigation strategies to stakeholders
- Develop detailed project plans, schedules, and resource allocation strategies while ensuring compliance objectives are met
- Serve as liaison between Quality, Regulatory Affairs, Operations, IT, and Product Management to ensure seamless execution of cross-functional initiatives
- Lead project meetings, provide status updates, and communicate risks and mitigation plans to stakeholders and senior management
- Track project milestones and deliverables
- Collaborate with cross-functional teams to integrate compliance requirements into business processes
- Develop and deliver strategic compliance training programs to ensure cross-functional awareness and accountability
- Act as a key member of the leadership team, contributing to the company's compliance strategy and overall quality initiatives
- Design, implement, and maintain the supplier qualification program in accordance with global compliance requirements (FDA, Health Canada, EMA, and TGA)
- Lead the qualification and onboarding process for new suppliers, including audits, technical assessments, and quality risk evaluations
- Establish and monitor supplier performance metrics
- Maintain up-to-date knowledge of relevant global regulatory requirements and industry best practices related to supplier management
- Develop and implement a regulatory strategy for market entry in Europe.
Requirements
- Bachelor's degree in Science
- Minimum five (5) to seven (7) years in a senior/responsible role within Quality, Compliance, or Regulatory Affairs, and a total of 10 years' professional experience
- Knowledge of FDA, Health Canada, TGA, and EMA regulations
- Knowledge of project management
- Proficient in Microsoft Office (Word, Outlook, and Excel) required
- Experience with Creatio and MasterControl is an asset
- Fluent in French and English (spoken and written) required
- Strong writing skills
- Reliable, accountable, and detail-oriented
- Organized with strong judgment and decision-making abilities
Benefits
- Work–life balance – 37.5-hour workweek with early-finish Fridays year-round, paid time off and vacation policy
- Invest in your health – Choice of modular plans, health spending account, and free telemedicine
- Your well-being matters – Employee wellness program offered
- Flexible work environment – Hybrid work schedule with home office reimbursement program
- A promising future – Learning and career development opportunities within Medisca
- Save for your future – Medisca contributes to a Deferred Profit Sharing Plan (DPSP) when you contribute to an RRSP
- Help us grow – Employee referral program
- Central location – Free parking/easily accessible by public transit; shopping center within walking distance for lunch or groceries
- We like to have fun – Company events throughout the year.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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